Dymista

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Azelastine hydrochloride 1 mg/g ((137 micrograms/spray)); Fluticasone propionate 0.365 mg/g ((50 micrograms/spray))

제공처:

Viatris Limited

INN (국제 이름):

Azelastine hydrochloride 1 mg/g ((137 micrograms/spray))

약제 형태:

Nasal spray suspension

구성:

Active: Azelastine hydrochloride 1 mg/g ((137 micrograms/spray)) Fluticasone propionate 0.365 mg/g ((50 micrograms/spray)) Excipient: Benzalkonium chloride Disodium edetate Glycerol Microcrystalline cellulose and carmellose sodium Nitrogen Phenethyl alcohol Polysorbate 80 Purified water

처방전 유형:

Pharmacy only

Manufactured by:

Evonik Technochemie GmbH

치료 징후:

Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

제품 요약:

Package - Contents - Shelf Life: Bottle, Type I amber coloured glass bottle and white nasal pump and actuator - 4 mL - 18 months from date of manufacture stored at or below 25°C. Do not refrigerate. Do not freeze. 6 months opened stored at or below 25°C. Do not refrigerate. Do not freeze. - Bottle, Type I amber coloured glass bottle and white nasal pump and actuator - 17 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate. Do not freeze. 6 months opened stored at or below 25°C. Do not refrigerate. Do not freeze.

승인 날짜:

2015-03-31

환자 정보 전단

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DYMISTA
®
_AZELASTINE HYDROCHLORIDE / FLUTICASONE PROPIONATE NASAL SPRAY
SUSPENSION_
_137 MICROGRAMS PER SPRAY / 50 MICROGRAMS PER SPRAY_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Dymista
.
This leaflet answers some common
questions about Dymista.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT DYMISTA IS
USED FOR
Dymista nasal spray relieves the
symptoms of allergies, for example:
symptoms relating to the nose -
runny nose, post-nasal drip,
sneezing, itchy or blocked nose and
symptoms relating to the eyes -
itchy, watery and red eyes.
Due to the fast relief and the anti-
inflammatory effect, Dymista nasal
spray is more effective on
symptoms relating to the nose and
eyes than either antihistamine or
corticosteroid therapy alone.
Dymista is sprayed into the nose to
treat allergic rhinitis (hay fever and
other allergies) and rhino
conjunctivitis (allergy-induced
symptoms in the nose and eyes) in
adults and children 12 years and
older where use of a combination
(intranasal antihistamine and
glucocorticoid) is appropriate.
Hay fever is an inflammation or
swelling of the nose lining (which
may cause blockage, runny nose,
itching and/or sneezing).
You may have symptoms only
during spring or summer. This type
of allergy is generally due to various
pollens. Some people may
experience symptoms all year
round. This is usually caused by
house dust mites, pets or moulds.
This medicine contains two active
ingredients: azelastine
hydrochloride and fluticasone
propionate.
Azelastine hydrochloride belongs to
a group of medicines called
antihistamines. Antihistamines work
by preventing the effects of
substances such as histamine that
the body produces as part of an
allergic r

제품 특성 요약

Page 1 of 13
NEW ZEALAND DATA SHEET
DYMISTA
®
1. PRODUCT NAME
Dymista nasal spray suspension.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dymista nasal spray is a fixed combination product containing the
following active ingredients:
azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1 mg azelastine hydrochloride and
0.365 mg fluticasone
propionate. One spray (137 mg) contains 125 micrograms of azelastine
(as the base) and
50 micrograms of fluticasone propionate.
EXCIPIENT(S) WITH KNOWN EFFECT:
Benzalkonium chloride: One spray (137 mg) of Dymista delivers 14
micrograms of benzalkonium
chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dymista is formulated as a white, homogeneous and re-dispersible
suspension. It is available as a
metered-spray suspension for intranasal administration.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Symptomatic treatment of moderate to severe allergic rhinitis and
rhino-conjunctivitis in adults and
children 12 years and older where use of a combination (intranasal
antihistamine and glucocorticoid)
is appropriate.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) _
One spray in each nostril twice daily (morning and evening). Do not
exceed this dose.
Do not use for longer than 6 months except on the advice of a
healthcare professional.
_SPECIAL POPULATIONS_
USE IN PAEDIATRIC PATIENTS (BELOW 12 YEARS OF AGE)
Dymista nasal spray is not recommended for use in children below 12
years of age as safety and
efficacy has not been established in this age group.
Page 2 of 13
USE IN THE ELDERLY
No dose adjustment is required in this population (see section 5.2).
USE IN RENAL AND HEPATIC IMPAIRMENT
No dose adjustment is required in patients with renal impairment or
mild to moderate hepatic
impairment (see section 5.2).
Caution is required when treating patients with severe hepatic
impairment (see section 5.2).
METHOD OF ADMINISTRATION
Dymista nasal spray is for administration